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A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies

RecruitingPhase 1Ages 18 Years - anyAllKumquat Biosciences Inc.
NCT06720987 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.

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📋 Eligibility rules (as published)
Inclusion Criteria: * PART 1 (monotherapy and combo therapy with KQB198): Histologically confirmed diagnosis of a solid tumor malignancy with either a KRAS G12C or KRAS G12S mutation. * PART 1 (combo therapy with Cetuximab) \& PART 2: Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with either a KRAS G12C or KRAS G12S mutation. * Unresectable or metastatic disease * No available treatment with curative intent * Adequate organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Active primary central nervous system tumors * Cardiac abnormalities * Active interstitial lung disease * Unable to swallow or GI condition that prevents absorption for patients in KQB198 combination cohorts
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What it tests

  • KQB365
  • Cetuximab
  • KQB198
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Where

11 sites
Mayo Clinic, Phoenix
Phoenix, United States
Sarah Cannon Cancer Institute at HealthONE
Denver, United States
Mayo Clinic, Jacksonville
Jacksonville, United States
Dana Farber Cancer Institute
Boston, United States
START Midwest
Grand Rapids, United States
Mayo Clinic, Rochester
Rochester, United States
Cleveland Clinic, Taussig Cancer Institute
Cleveland, United States
OU Health Stephenson Cancer Center
Oklahoma City, United States

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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